Tuesday, May 29, 2007

Another Contact Lens Solution Recalled - May 29, 2007

Advanced Medical Optics (AMO) announced a recall of one of their contact lens solutions on May 25 because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). This could be a direct GMP issue - contamination during the manufacturing process.

Last November AMO recalled 18 batches of contact lens solutions for contamination problems. Just last week AMO said they would try to acquire Bausch and Lomb, who announced last week that they were being acquired by a private equity investment firm.

Read FDA's announcement of AMO's voluntary recall. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.


Perhaps the management at AMO should be focusing more energy on producing high quality products and less on acquiring competitors.

Is it just us, or is there a considerable increase in contamination issues lately?

It's a good idea to conduct an internal audit at your firm and focus on cleaning and reducing the risk of contamination.

GMP Training Systems, Inc.
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Serving 1153 clients since 1996

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Monday, May 21, 2007

How a GMP Issue Can Take Down a Company - May 21, 2007

You may remember last May (2006) when Bausch and Lomb recalled one of its contact lens cleaning solutions (a $100 million-a-year product) because of an outbreak of potentially blinding infections. At first they denied that there was a problem with the product, but enough evidence surfaced to warrant the recall.

It is no surprise that B&L’s sales for 2006 fell significantly. In their struggle to recover, they have agreed to a buyout by a private equity investment firm. B&L was started in 1853 by John Jacob Bausch, a German immigrant, who set up an optical goods shop in Rochester, NY. He borrowed $60 from his partner Henry Lomb.

It’s a sad tale that after 154 years; a company is taken down by a contaminated product. Clearly this was a GMP issue, and could have been prevented.

Some background on this case.

We reported in April 2006 that the fungus infection problem surfaced and B&L’s CEO at that time said that their product was "as safe and effective as anything on the market." Four weeks later, one day after receiving an eleven page 483 from FDA, B&L issued the recall. Five months later, In October 2006, B&L received an eleven page Warning Letter from FDA. Now they’re being bought out. This is a classic example of what we call “the death spiral.”

We generally find the death spiral syndrome where GMP and Quality are not part of a company’s culture. Some companies “Get it” and some companies “Don’t get it.”

Sadly, for the customers and employees of B&L, their current management “Didn’t get it.”

Read the 483 and Warning Letter issued to B&L in 2006. Go to:
www.gmptrainingsystems.com/asp/resources.asp
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GMP Training Systems, Inc.

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Serving 1147 clients since 1996

Upcoming educational programs:
Web seminars
Digging for the Truth in Gas Chromatography series
May 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
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Our GMP Boot Camp is filling up fast.
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Tuesday, May 15, 2007

First Peter Pan, Now Hostess - May 15, 2007

American icons are falling like dominos. A few weeks ago, Peter Pan Peanut Butter was recalled for salmonella contamination. Now Hostess is recalling one of their products.

FDA announced on May 14 the voluntary recall of 3.25-ounce snack packages of Hostess Mini Pound Cakes. FDA said that Interstate Brands Corp. recalled the packages due to a packaging error. Officials said some of the packages might contain Hostess Carrot Cake, which is made with walnuts, posing a potential life-threatening problem for people who have an allergy or severe sensitivity to walnuts.

Training Tip
This mix-up is HUGE - putting the product in the packaging for a different product. Use this example in your GMP training sessions to emphasize the need to conduct a thorough line clearance procedure in between different products. Discuss the potential cost to the company if this were a pharmaceutical or medical device product.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1139 clients since 1996

Upcoming educational programs:
Web seminars
HPLC Troubleshooting & Preventive Maintenance series
May 18 and 24
Digging for the Truth in Gas Chromatography series
May 16, 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp June 6 – 7 Anaheim, CA
GMP Boot Camp July 18 - 19 Virginia Beach,VA
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Thursday, May 10, 2007

More Controversy at FDA - May 10

A Food and Drug Administration plan to close seven of 13 field laboratories has angered some lawmakers, government workers and safety advocates, who fear the move will chase away skilled veteran employees and hurt the FDA's ability to respond to public health emergencies.

Several of the facilities helped investigate the recent pet food scare and E. coli and salmonella outbreaks in spinach and peanut butter. On the heels of these crises, the proposed lab closings have been met with strong suspicion.

"In the middle of all these outbreaks and contamination issues, the timing of the proposal is extraordinarily bad," said Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America.

Read this story from McClatchy News. Go to:
www.gmptrainingsystems.com/asp/rersources.asp
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Our take on this issue
Over the years we've learned that timing is critical when striving for acceptance of a plan that represents change. This may be a good plan, but the timing is bad, given all the criticism FDA has been taking recently.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1131 clients since 1996

Upcoming educational programs:
Web seminars
HPLC Troubleshooting & Preventive Maintenance series
May 11, 18, 24
Digging for the Truth in Gas Chromatography series
May 16, 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp June 6 – 7 Anaheim, CA
GMP Boot Camp July 18 - 19 Virginia Beach,VA
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Tuesday, May 01, 2007

Senate Looks to Give FDA More Power, More Money - May 1, 2007

The Senate began debate on Monday on a bill that could fundamentally change the way the FDA operates by giving it more power and money to ensure that drugs are as safe as advertised. The measure, which has bipartisan support, would renew and increase the fees paid by regulated drug companies.

“This is the most important legislation for FDA in at least 10 years and, probably, forever on issues of drug safety,” said Dr. Mark B. McClellan, a former food and drug commissioner.

Dr. David A. Kessler, another former commissioner, said, “This is a pivotal moment in FDA’s history, as important as 1938 or 1962, when Congress gave the agency its fundamental responsibilities.”

“The FDA should be the gold standard for safety, but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs,” Sen. Edward Kennedy said on the Senate floor.

Read this article from The New York Times. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1125 clients since 1996

Upcoming educational programs:
Web seminars
HPLC Troubleshooting & Preventive Maintenance series

May 4, 11, 18, 24
Digging for the Truth in Gas Chromatography series
May 16, 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp June 6 – 7 Anaheim, CA

GMP Boot Camp July 18 - 19 Virginia Beach, VA
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